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Regulatory Insights From 27 Years of Artificial Intelligence/Machine Learning–Enabled Medical Device Recalls in the United States: Implications for Future Governance

Regulatory Insights From 27 Years of Artificial Intelligence/Machine Learning–Enabled Medical Device Recalls in the United States: Implications for Future Governance

Furthermore, in the FDA regulatory procedures manual, chapter 7 (recall procedures) states that when recalls are classified as Class I or significant Class II recalls, the need for an establishment inspection should be assessed to determine the root cause of the problem and document any potential regulatory actions (7-5-1, 3 Establishment Inspection) [9,14].

Wei-Pin Chen, Wei-Guang Teng, C Benson Kuo, Yu-Jui Yen, Jian-Yu Lian, Matthew Sing, Peng-Ting Chen

JMIR Med Inform 2025;13:e67552

GamePlan4Care, a Web-Based Adaptation of the Resources for Enhancing Alzheimer’s Caregiver Health II Intervention for Family Caregivers of Persons Living With Dementia: Formative, Qualitative Usability Testing Study

GamePlan4Care, a Web-Based Adaptation of the Resources for Enhancing Alzheimer’s Caregiver Health II Intervention for Family Caregivers of Persons Living With Dementia: Formative, Qualitative Usability Testing Study

For example, one participant said, “It is not something I would just watch and put it away. I could have these printed out in my little book.” Another participant stated, “I like how they are almost making it [the program] like a continuing education.” Similarly, another participant said, “It’s not too long, it gives information, it makes me want to come back and see what else is there.”

Jinmyoung Cho, Thomas Birchfield, Jennifer L Thorud, Marcia G Ory, Alan B Stevens

JMIR Form Res 2025;9:e60143

Artificial Intelligence–Enabled Facial Privacy Protection for Ocular Diagnosis: Development and Validation Study

Artificial Intelligence–Enabled Facial Privacy Protection for Ocular Diagnosis: Development and Validation Study

Pixel distances (|A|, |B|, |CD|, |EF|, |GH|, and |IJ|) along the x- and y-axes for both eyes were calculated between the iris center (o and o’) and reference points (a, b, c, d, e, f, g, h, i, j) in 1136 healthy individuals (see Figures 3 II,3). The difference in pixel distances along the x-axis between the left and right eyes was denoted as |A-B|. Outlier detection was performed using the IQR method, excluding data points outside 1.5 times the IQR from the lower and upper quartiles.

Haizhu Tan, Hongyu Chen, Zhenmao Wang, Mingguang He, Chiyu Wei, Lei Sun, Xueqin Wang, Danli Shi, Chengcheng Huang, Anping Guo

J Med Internet Res 2025;27:e66873

User-Driven Development of a Digital Behavioral Intervention for Chronic Pain: Multimethod Multiphase Study

User-Driven Development of a Digital Behavioral Intervention for Chronic Pain: Multimethod Multiphase Study

I put more stock in ACT. Acceptance, which is something I’ve worked really hard on because I’ve been a bit black or white.” [Patient 5] “I personally would have had a more difficult time if [I] met the patients face-to-face in this type of treatment without any support... Having a treatment program that you follow, I feel that the knowledge I have [then] about chronic pain is good enough.”

Afra Selma Taygar, Sara Laureen Bartels, Rocío de la Vega, Ida Flink, Linnéa Engman, Suzanne Petersson, Sophie I Johnsson, Katja Boersma, Lance M McCracken, Rikard K Wicksell

JMIR Form Res 2025;9:e74064

Trends in Avoidable Hospitalizations Before and During the COVID-19 Pandemic: Multiple Cross-Sectional Study Using Administrative Data From Beijing, China

Trends in Avoidable Hospitalizations Before and During the COVID-19 Pandemic: Multiple Cross-Sectional Study Using Administrative Data From Beijing, China

The model can be written as follows: where the subscript i denotes the district in Beijing and t denotes each month from January 2016 to December 2021. The dependent variable Yit is the crude or standardized monthly AH rate for each district. The independent variable COVIDit is a dummy variable that takes 1 if the district experienced 1 or more newly confirmed COVID-19 cases in the current month. Otherwise, it equals 0.

Xiangzhen Wang, Yin Chen, Yuqi Ta, Moning Guo, Hongqiao Fu

JMIR Public Health Surveill 2025;11:e69768